N/A
N=24
Open-Label Study for Shoulder Dislocation Using MG-1
Shoulder Dislocation
Bottom Line
View on ClinicalTrials.gov: NCT01528319 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2014
Primary outcome: Primary: Surgery Success — 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MG-1 (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson K.K. Medical Company
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgery Success |
23 | — |
| PRIMARY Clinical Function Evaluation |
82.7; 88.9 | — |
| SECONDARY Procedure Success |
23 | — |
| SECONDARY Clinical Function Evaluation |
82.7; 88.9 | — |
| SECONDARY Number of Participants With Abnormal Changes in One or More Laboratory Tests |
1 | — |
| SECONDARY Adverse Event Evaluation |
18 | — |
Summary
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Eligibility Criteria
Inclusion Criteria
- Patients with dislocation of the shoulder and indicated for arthroscopic Bankart repair
- Patients of 16 years or older
- Patients who understand the contents of the study and from whom a written consent can be obtained
- Patients who can visit the hospital for follow-ups after surgery
Exclusion Criteria
- Patients with serious complications
- Patients with comminuted fracture which may prevent fixation of the anchors
- Patients with the following diseases or conditions which may delay healing
- Lack of blood, infection, etc.
- Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
- Tissues around the surgical site are not healthy under steroid therapy or chemotherapy
- Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
- Patients with dementia
- Patients with a history of allergy to glycolic acid, poly-L-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane
- Patients who cannot undergo general anesthesia
- Patients who cannot undergo plain X-ray examination or MRI examination
- Patients with previous bone grafting in the shoulder joint
- Patients who participated in another clinical trial within past 3 months
- Patients who are pregnant or lactating. Patients who plan to be pregnant within a year
- Patients judged to be inappropriate for the study by the (sub)investigator
Data sourced from ClinicalTrials.gov (NCT01528319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.